MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH; INTRODUCER, CATHETER

Catalog Number	54-54501
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	03/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has been returned to the manufacturing facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, evaluation code 20 has been referenced in the conclusions.A review of the device history record of the product code/lot# combination was conducted with no relevant findings.See mdr 1118880-2017-00029 for the first device reported.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.Device is currently under investigation.
Event or Problem Description
The user facility reported the valve was disconnected when the destination package was opened.Follow up communication with the user facility reported: attempted to screw valve down but would not "lock"; a second unit was opened and used; when the physician removed a catheter through the valve the valve "popped off"; the procedure was successful; and there was no impact to the patient.Additional information was received on 4/6/2017: blood loss was minimal as they were able to secure the valve immediately.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The dilator and the sheath were returned to the manufacturer for evaluation.A visual evaluation confirmed the valve was attached to the sheath.Sheath hub to ccv valve fit was conducted and confirmed to meet manufacturer specification.A review of the device history record of the involved product/lot # combination was conducted with no relevant findings.A search of the complaint file found one similar report with the involved product code/lot# combination.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• Brand Name: PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 6525844
• Report Number: 1118880-2017-00030
• Device Sequence Number: 1374003
• Product Code: DYB
• UDI-Device Identifier: 00389701008912
• UDI-Public: (01)00389701008912(17)190531(10)UP07
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K081046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 54-54501
• Device Lot Number: UP07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 05/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GLIDE CATHETER